Insights

With the growing demand for advanced therapies like biologics and cell and gene therapies, the pressure is on to produce medicine faster but with impeccable quality. As the complexity of manufacturing processes evolves so must the trusted MES. 

In 2025, MES will no longer just track batches or manage workflows. Instead, it is connecting people, processes, and cutting-edge technologies like AI, digital twins, and IoT. MES has evolved to become the digital backbone of modern biomanufacturing, enabling smarter, greener, and more agile operations. 

In this blog, we’ll explore the top 5 MES trends shaping biomanufacturing in 2025.

 

1. Focus on Pharma 4.0 initiatives

Biomanufacturers are fully embracing Industry 4.0, and MES is at the heart of it. MES is central to this transformation by integrating sensors, automated systems, and analytics platforms. Not only does it create smarter production environments, but it also redefines what’s possible in those. 

• MES systems integrate directly with IoT sensors, enabling real-time tracking of equipment and processes to ensure consistent quality and reduce downtime. For example, IoT sensors integrated with MES can detect temperature fluctuations in bioreactors, ensuring batch integrity and minimizing waste. This connectivity allows manufacturers to proactively identify inefficiencies and address issues before they escalate. 

• AI and machine learning are transforming predictive maintenance by anticipating and minimizing equipment failures. They also optimize production schedules, helping manufacturers reduce downtime and streamline workflows. 

• Digital twins allow manufacturers to create virtual replicas of processes, enabling them to simulate and test changes without disrupting operations. This innovation minimizes risks, optimizes production, and accelerates improvements.  

With MES and Industry 4.0, manufacturers have access to smarter, more agile manufacturing systems that are essential for meeting the growing complexity of biomanufacturing.

 

2. MES customization: Different solutions for different needs

In 2025, the trend toward tailored MES solutions will accelerate. No single MES system fits every biomanufacturer’s needs. Companies are now exploring different types of MES platforms, each designed to address specific operational challenges. 

Proven platforms provide stability and compliance, making them ideal for highly regulated environments. While robust and reliable, they can struggle to adapt to the fast-paced demands of modern innovation. Cloud-based solutions and Composable, app-based platforms are two other key types of MES that are gaining momentum. Hybrid MES Solutions combining on-premises reliability with cloud-based flexibility. Finally, niche platforms address specific requirements, such as upstream biologics production or lab data integration, providing high efficiency in specialized fields. 

Choosing the right MES depends on priorities. Whether it’s stability, scalability, or agility, each system has strengths and trade-offs. This trend reflects the need for customized MES to meet the growing complexity of biomanufacturing. 

 

3. Adoption of Cloud-based MES solutions

Cloud-based MES platforms, like L7 ESP, are transforming how manufacturing systems work. They offer the scalability and flexibility needed for multi-site manufacturers and companies expanding production. These platforms are especially valuable when transitioning from clinical-scale to commercial manufacturing. They also reduce infrastructure costs by eliminating the need for extensive server maintenance. They integrate seamlessly with ERP, LIMS, and other tools, streamlining workflows and decision-making.   

However, regulatory compliance remains a significant challenge. In industries like biopharma, cloud platforms must meet strict requirements such as 21 CFR Part 11 or EU GMP Annex 11. Validation processes must ensure data integrity, audit trails, and consistent performance. This can be complex given the frequent updates in cloud environments. Finally, some regulators mandate that sensitive data remain within specific regions, something going against the idea of data in the cloud. 

Data security is another critical concern. Cloud-based MES must protect sensitive manufacturing and patient data from breaches and unauthorized access with features like encryption, and multi-factor authentication. 

Despite these challenges, cloud-based MES is becoming essential for modern manufacturers. With proper validation and security measures, these platforms offer a secure, compliant, and scalable solution, enabling manufacturers to innovate while adhering to regulatory standards. 

 

4. Modular and flexible App-based solutions

Traditional MES platforms often required extensive customization, making them costly and hard to adapt. Modular MES systems address this with plug-and-play components, letting manufacturers use only the features they need, such as scheduling or quality management. This reduces costs and allows for quick adjustments to new products or regulations. 

Composable, app-based platforms like Tulip go further, offering unmatched flexibility. Companies can quickly create and adapt applications, making them ideal for agile workflows. These systems are particularly useful in dynamic industries like cell and gene therapy, where needs change rapidly. Their user-driven approach empowers teams to innovate and respond with speed.  

However, this flexibility comes with trade-offs. Rapid evolution can cause integration challenges with legacy systems, leading to potential compatibility issues. Additionally, in regulated industries, validation and compliance requirements can slow innovation. Rigorous testing is needed for every adjustment to meet strict standards. 

 Despite these challenges, composable MES platforms are a powerful choice for companies seeking agility. With careful planning for integration and compliance, they offer a way to drive innovation while maintaining reliability. 

 

5. MES and the future of green manufacturing

Sustainability is now a top priority in biomanufacturing and certifications like Ecovadis are becoming standard requirements. MES systems are essential tools for supporting greener practices and help meet global sustainability goals  

These systems monitor energy use and waste output in real-time. This helps manufacturers identify inefficiencies and reduce consumption. For example, MES can pinpoint energy-intensive processes and enable adjustments that significantly lower usage. Studies show that MES-driven energy optimization has achieved reductions of up to 25% in some facilities. By maintaining consistent quality, MES also minimizes waste by reducing the need for rework and scrap, saving both resources and costs. 

In facilities adopting renewable energy, MES can optimize production schedules to align with periods of peak energy availability. This not only lowers environmental impact but also improves cost efficiency. Additionally, MES tracks sustainability metrics such as carbon emissions and water usage, ensuring regulatory compliance. 

By using MES the right way manufacturers can lower their carbon footprint and meet the demands of an eco-conscious market. MES is proving that environmental and business goals can go hand in hand, making it an essential tool for the future of green manufacturing. 

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These trends highlight how MES is evolving to meet the complex demands of biomanufacturing in 2025. Now is the time to take a close look at your current MES system. 

• Does it support your goals for efficiency, compliance, and sustainability? 

• Is it flexible enough to adapt to changing production needs, such as new regulations or scaling operations? 

• Can it integrate seamlessly with other systems like ERP or LIMS to ensure a connected workflow? 

• Are you leveraging its full potential to monitor energy use, reduce waste, and achieve sustainability targets? 

If the answer to any of these questions is no, it may be time to explore new solutions. Modern MES platforms—whether modular, cloud-based, or composable—offer opportunities to fill these gaps. By aligning your MES with your strategic goals, you can drive greater efficiency, ensure compliance, and take meaningful steps toward a sustainable future. Don’t let outdated systems hold you back—start your assessment today and stay ahead in a rapidly evolving industry.